Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Danol capsules are recommended for the treatment of:
Endometriosis: treatment of endometriosis-associated symptoms or/and to reduce the extent of endometriosis foci. Danazol may be used either in conjunction with surgery or, as sole hormonal therapy, in patients not responding to other treatments.
Benign fibrocystic breast disease: symptomatic relief of severe pain and tenderness. Danazol should be used only in patients not responsive to other therapeutic measures or for whom such measures are inadvisable.
Danol capsules should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient’s response. A reduction in dosage once a satisfactory response has been achieved may prove possible. In fertile females, Danol capsules should be started during menstruation, preferably on the first day, to avoid exposing a pregnancy to its possible effects. Where doubt exists, appropriate checks should be made to exclude pregnancy before starting medication. Females of child-bearing age should employ non-hormonal contraception throughout the course of treatment.
In endometriosis the recommended dosage is 200mg to 800mg daily in a course of treatment lasting normally three to six months. Dosage should be increased if normal cyclical bleeding still persists after two months therapy, a higher dosage (not exceeding 800mg per day) may also be needed for severe disease.
In benign fibrocystic breast disease, treatment should commence at a dose of 300mg daily, a course of treatment normally lasting 3 to 6 months.
Danol is not recommended.
Danol is not recommended.
The capsules are for oral administration.
Available evidence suggests that acute overdosage would be unlikely to give rise to immediate serious reaction.
In the case of acute overdose consideration should be given to reducing the absorption of the drug with activated charcoal and the patient should be kept under observation in case of any delayed reactions.
Shelf life: 3 years.
None.
PVC blister pack compound of polyvinyl chloride (thickness 250µm) sealed to aluminium foil (thickness 20µm). The blisters are then packed in a cardboard carton.
Pack sizes: 50, 60 and 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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